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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

India Sets Terms for State Regulatory Investment Plan

The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals.

Ministry of Health officials have drafted the MoU in an attempt to ensure the investment has the desired effect on the regulatory infrastructure of states in India. Every state must create an action plan for each of the three years in which they are set to receive cash through the stimulus program, but the overarching goals of all the plans are being guided by centralized objectives. Ministry of Health officials are most concerned about weak drug controls, testing labs, training and IT services.

The states are expected to commit some of their own money to the improvements. Under the terms of the MoU, most states must contribute Rs 25 for every Rs 75 committed by the investment plan. A handful of states will only have to provide Rs 10 for every Rs 90 from the government. Regardless of the model, the government wants to see its investment make an impact. If states fail to achieve certain goals, the government can reduce, suspend or cancel its contributions.

New Zealand Starts Revision of 34-Year old Medicine Legislation

The New Zealand government has started work on a revision of the Medicines Act of 1981 and its associated regulations. Officials are aiming to introduce a proposed replacement to the 34-year-old legislation to parliament for discussion next year.

Work on the development of a new therapeutic products regulatory regime was initiated following the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) project. Australia and New Zealand shut down the harmonization-focused ANZTPA collaboration in November. The decision left New Zealand looking for a way to independently update its regulatory regime, which as it stands is lacking in several important areas.

The new Medicines Act is expected to fully regulate medical devices and cell therapies for the first time in New Zealand. Officials also want to ensure the legislation has the flexibility to cope with the evolution of technologies after they bring the document into force. Full details of how ministers hope to achieve these goals will emerge when the legislation is introduced into parliament next year. For now, the government has said little beyond its desire to align its efforts with global standards.

DCGI Seeks Feedback on Plan to Reclassify Some Nutraceuticals as Drugs

The Drug Controller General of India (DCGI) is seeking feedback on the proposed reclassification of certain nutraceuticals as drugs. DCGI initiated the consultation at the request of the Drug Technical Advisory Board (DTAB), which has written a report on the line between nutraceuticals and drugs.

In the report, DTAB argues that products currently sold as nutraceuticals by Pfizer, Ranbaxy and other manufacturers should be reclassified as drugs. The proposal is underpinned by a belief that if a tablet, capsule or granule contains ingredients covered by Schedule V of the Drugs and Cosmetics Rules, 1945, which includes vitamins such as A, D and folic acid, then it is a drug. DTAB thinks such products should be classed as safe unless they include ingredients from beyond Schedule V.

Any product that claims to treat, prevent or mitigate a disease will also be classed as a drug under the DTAB plan. Having written the report, DTAB asked DCGI to release it for public consultation. DCGI is accepting feedback on the proposals for one month, after which officials will review the comments before deciding on a way forward.

DRAP Gives Industry 30 Days to Fix Incomplete Applications

The Drug Regulatory Authority of Pakistan (DRAP) has given firms that filed registration applications that are noncompliant with its current fee structure 30 days to provide the extra money. Some filings have been rendered noncompliant by a September 2012 revision of the fee structure.

DRAP made the statement after the Pakistan Pharmaceutical Manufacturers Association (PPMA) asked it to clarify the status of the pending applications and the order in which it is working through the backlog. Applicants that provided the differential fee on time are at the top of the list. DRAP will add any companies that send money in the next 30 days to a second list that it will start working through once it has dealt with the first group of applicants.

The statement gives some clarity to a situation that has been developing for several years. DRAP introduced the new fee structure in a document titled SRO 1117(I)/2012 in September 2012. PPMA went on to ask DRAP to consider the status and priority of pending applications, something the regulator did at a meeting of its policy board in April. The outcome of that meeting was communicated to PPMA and the public this month.

India Calls for Comment on Regulation of Online Drug Sales

The subcommittee set up to consider regulation of online drug sales in India is seeking comments from the public. Members of the subcommittee decided to incorporate the views of individuals, trade groups and businesses into their deliberations at their recently-held introductory meeting.

Dr Harshdeep Kamble, head of the Maharashtra Food and Drug Administration and chair of the subcommittee, is accepting comments on the topic until 28 September. The subcommittee is yet to provide any official statements on how it intends to propose regulating online drug sales, so, for now, the focus is on gathering general views, not critiques of specific plans. That will change once the subcommittee decides on its recommendations.

The lack of an official position from the subcommittee has done little to slow discussions about the topic. Members of the subcommittee have anonymously told the media the plan is to allow online drug sales provided certain safeguards are put in place, while pharmacist trade groups have already vowed to fight any such proposal.

Other News:

Australia’s Therapeutic Goods Administration(TGA) has published feedback it received on five draft monographs it released for consultation. TGA argued against the need to make many of the changes proposed by the four organizations that submitted feedback, but did agree to widen the expiry limits for the active ingredients in hand sanitizers. TGA Notice

PPMA is continuing its fight against legislation to clampdown on fake and substandard products in Punjab. The Pakistani trade group has called for the repeal of the Punjab Drugs Amendment Ordinance, 2015 on the grounds that it conflates manufacturers of substandard and counterfeit products, leading to strong sentences against legitimate producers that make mistakes. Dental News

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is meeting with government and regulatory leaders this week to discuss the main issues faced by exporters. Pharmexcil is hoping the meeting will provide a forum in which manufacturers can communicate their concerns and officials can explain what they are doing to help. PharmaBiz, Pharmexcil Notice

TGA has issued an alert about Mathys Orthopaedics’ seleXys TH+ and TPS acetabular shells. The products, which were used in hip replacements, have been associated with higher than expected revision rates. Neither product is still on the Australian Register of Therapeutic Goods, but surgeons who used them prior to their cancellations are being advised to follow up with patients. TGA Notice